Patient leaflet - IBUPROFEN 200 MG FILM-COATED TABLETS
1. What Ibuprofen Film-coated Tablet is and what it is used for
2. What you need to know before you take Ibuprofen Film-coated Tablets
3. How to take Ibuprofen Film-coated Tablets
4. Possible side effects
5. How to store Ibuprofen Film-coated Tablets
6. Contents of the pack and other information
1. what ibuprofen film-coated tablets is and what it is used for
Ibuprofen Film-coated Tablets contain ibuprofen, which belongs to a group of medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) which work to reduce pain and fever.
This medicine is used for the short term symptomatic treatment of mild to moderate pain such as headache, period pain, dental pain, and fever.
You must talk to a doctor if you do not feel better or if you feel worse after 3 days with fever and 4 days with pain.
2. what you need to know before you take ibuprofen film-coated tablets
Do not take Ibuprofen Film-coated Tablets if you:
§ are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6)
§ have ever suffered from shortness of breath, asthma, a runny nose, swelling or hives after using acetylsalicylic acid (known as aspirin) or other similar painkillers (NSAIDs)
§ have (or have had two or more episodes of) a stomach ulcer, or bleeding of the stomach
§ have a history of gastro-intestinal bleeding or perforation related to previous NSAID therapy
§ have severe kidney or severe heart failure or severe liver failure
§ are bleeding, including any bleeding within the brain (cerebrovascular bleeding)
§ are suffering from unclarified blood-formation disturbances
§ are severely dehydrated (caused by vomiting, diarrhoea or insufficient fluid intake)
§ are in the last 3 months of pregnancy.
Warnings and precautions
Anti-inflammatory/pain killer medicines like ibuprofen may be associated with a small increased risk of heart attack or stroke, particularly when used at high doses. Do not exceed the recommended dose or duration of treatment.
You should discuss your treatment with your doctor or pharmacist before taking Ibuprofen Film-coated Tablets:
§ if you develop any skin rash, lesions of the mucous membranes, blisters or other signs of allergy since this can be the first signs of a very serious skin reaction, you should stop taking Ibuprofen Film-coated Tablets and seek medical attention immediately. Serious skin reactions have been reported in association with ibuprofen film coated tablets treatment. See section 4.
§ Ibuprofen Film-coated Tablets may hide signs of infections such as fever and pain. It is therefore possible that Ibuprofen Film-coated Tablets may delay appropriate treatment of infection, which may lead to an increased risk of complications. This has been observed in pneumonia caused by bacteria and bacterial skin infections related to chickenpox. If you take this medicine while you have an infection and your symptoms of the infection persist or worsen, consult a doctor without delay.
§ if you have hereditary blood formation disorder (e.g. acute intermittent porphyria)
§ if you are elderly because you may be at more risk of having side effects to NSAIDs, particularly gastrointestinal bleeding and perforation which may be fatal..
§ if you have or have suffered from asthma or have allergies as shortness of breath may occur
§ if you suffer from hayfever, nasal polyps or chronic obstructive respiratory disorders an increased risk of allergic reactions exists. The allergic reactions may present as asthma attacks (so-called analgesic asthma), Quincke's oedema or urticaria
§ during chickenpox (varicella) it is advisable to avoid use of Ibuprofen Film-coated Tablets § if you have reduced liver or kidney function
§ directly after major surgery
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§ if you have Crohn's disease or ulcerative colitis as these conditions may be worsen.
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§ If you have Systemic Lupus Erythematosus (SLE) or mixed connective tissue disease -illnesses which affect your immune system.
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§ if you have heart problems including heart failure, angina (chest pain), or if you have had a heart attack, bypass surgery, peripheral artery disease (poor circulation in the legs of feet due to narrow or blocked arteries), or any kind of stroke (including ‚mini-stroke‘ or transient ischaemic attack “TIA”)>
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§ if you have high blood pressure, diabetes, high cholesterol, have a family history of heart disease or stroke, or if you are a smoker.
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§ In prolonged administration of Ibuprofen Film-coated Tablets regular checking of your liver values, the kidney function, as well as of the blood count, is required
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§ The use with concomitant NSAIDs, including cyclo-oxygenase-2 specific inhibitors, increases risk of adverse reactions (see section “If you are taking other medicines” below) and should be avoided.
Side effects may be minimised by using the lowest effective dose for the shortest possible duration necessary to relief symptoms.
Gastrointestinal bleeding, ulceration or perforation, which can be fatal, has been reported during treatment with all NSAIDs. Such effects occurred at any time during therapy, with or without warning symptoms or a previous history of serious events in the gastrointestinal tract.
The risk of developing gastrointestinal bleeding, ulcers and perforation is higher with the increasing NSAID doses and is higher in patients with a history of ulcer, especially with complications of bleeding or perforation (see section 2 “DO NOT take Ibuprofen Film-coated Tablets”) and in elderly patients. These patients should start treatment at the lowest available dose. For these patients, as well as patients who require additional therapy with low-dose acetylsalicylic acid or other medicines likely to increase gastrointestinal risk, combination treatment with protective active substances (e.g. misoprostol or proton pump inhibitors) should be considered.
If you have a history of side effects affecting the gastrointestinal tract, particularly if you are elderly, you should report all unusual abdominal symptoms (especially gastrointestinal bleeding), especially in the initial stages of therapy.
Caution is advised if you are receiving other medicines that can increase the risk of ulcers or bleeding, such as oral corticosteroids, anticoagulants (blood-thinners) such as warfarin, selective serotonin reuptake inhibitors (used to treat psychiatric disorders including depression) or platelet aggregation inhibitors such as acetylsalicylic acid (see section 2 “Other medicines Ibuprofen Film-coated Tablets”).
Treatment must be stopped and a doctor consulted if you develop gastrointestinal bleeding or ulcers during treatment with Ibuprofen Film-coated Tablets.
Very rarely, severe acute hypersensitivity reactions (e.g. anaphylactic shock) have been observed. Stop treatment immediately at the first signs of hypersensitivity reaction after taking Ibuprofen Film-coated Tablets and contact immediately a doctor.
Ibuprofen can temporarily inhibit blood platelet function (blood platelet aggregation). Patients with blood clotting disorders should therefore be carefully monitored.
Ibuprofen may mask signs of infection and fever.
In general the habitual use of (several sorts of) analgesics can lead to lasting severe kidney problems. This risk may be increased under physical strain associated with loss of salt and dehydration. Therefore it should be avoided.
There is a risk of renal impairment in dehydrated adolescents.
Prolonged use of any type of painkiller for headaches can make them worse. If this situation is experienced or suspected, medical advice should be obtained and treatment should be discontinued. The diagnosis of medication overuse headache (MOH) should be suspected in patients who have frequent or daily headaches despite (or because of) the regular use of headache medications.
Consult a doctor before using Ibuprofen Film-coated Tablets if any of the above mentioned conditions concern you.
Other medicines and Ibuprofen Film-coated Tablets
Ibuprofen Film-coated Tablets may affect or be affected by some medicines. For example: – medicines that are anti-coagulants (i.e. thin blood/prevent clotting e.g.
aspirin/acetylsalicylic acid, warfarin, ticlopidine),
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– medicines that reduce high blood pressure (ACE-inhibitors such as captopril, betablockers such as atenolol medicines, angiotensin-II receptors antagonists such as losartan.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. In particular, tell them if you are taking:
| aspirin/acetylsalicylic acid, or other NSAIDs (anti- inflammatories and analgesics) | since this may increase the risk of gastrointestinal ulcers or bleeding |
| digoxin (for heart insufficiency) | since this may increase serum level of these medicines |
| glucocorticoids (medicinal products containing cortisone or cortisone-like substances) | since this may increase the risk of gastrointestinal ulcers or bleeding |
| anti-platelet agents (such as ticlopidine) | since this may increase the risk of bleeding |
| medicines for thinning the blood (such as warfarin) | since ibuprofen may enhance the effects of these medicines |
| Mifepristone | since decrease of efficacy of the medicinal product can occur |
| Sulphonylureas | Since rare reports of hypoglycaemia in patients |
| phenytoin (for epilepsy) | since this may increase serum level of these medicines |
| selective serotonin reuptake inhibitors (medicines used for depression) | as these may increase the risk of gastrointestinal bleeding |
| Lithium (a medicine for manic depressive illness and depression) | since the effect of lithium may be enhanced |
| probenecid and sulfinpyrazones (medicines for gout) | since the excretion of ibuprofen may be delayed |
| medicines for high blood pressure and water tablets | since ibuprofens may diminish the effects of these medicines and there could be a possible increased risk for the kidney |
| aminoglycosides (a certain class of antibiotics) | NSAIDs may decrease the excretion of aminoglycosides |
| potassium sparing diuretics | since this may lead to hyperkalaemia |
| methotrexate (a medicine for cancer or rheumatism) | since this may lead to elevated concentration of methotrexate and increase in its toxic effect. |
| Colestyramine | Since reduces the absorption of ibuprofen |
| tacrolimus and cyclosporine (immunosuppressive medicines) | since kidney damage may occur |
| zidovudine: (a medicine for treating Aids) | since the use of Ibuprofen Tablets may result in an increased risk of bleeding into a joint or a bleeding that leads to swelling in HIV (+) haemophiliacs |
| Ginkgo biloba (a herbal medicine) | increased risk of bleeding in concomitant use with NSAIDs |
| quinolone antibioticssince | the risk for convulsions may be increased |
| Voriconazole, fluconazole (CYP2C9 inhibitors) used for fungal infections) | since the effect of ibuprofen may be enhanced. Reduction of the ibuprofen dose should be considered, particularly when high-dose ibuprofen is administered with either voriconazole or fluconazole |
Some other medicines may also affect or be affected by the treatment of Ibuprofen Film-coated Tablets. You should therefore always seek the advice of your doctor or pharmacist before you use Ibuprofen Film-coated Tablets with other medicines.
Ibuprofen Film-coated Tablets with alcohol
Some side effects, such as those affecting the gastrointestinal system or the central nervous system can be more likely when alcohol is taken at the same time as Ibuprofen Film-coated Tablets.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Do not take Ibuprofen Film-coated Tablets in the last three months of pregnancy. Intake of ibuprofen should be avoided by women who plan pregnancy or are pregnant. Treatment during any part of pregnancy should take place only on doctors advice.
Breast-feeding
This medicine may be used during breast feeding for a maximum of 3 days (when you are treating a fever) or 4 days (for the treatment of pain), as only small amounts of this medicine passes into breast milk.
Fertility
These tablets belong to a group of medicines (NSAIDs), which may impair fertility in
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women. This is reversible on stopping the medicine.
Driving and using machines
As central nervous side effects such as tiredness and dizziness may occur on use of Ibuprofen Film-coated Tablets at higher dosage, the ability to react and the ability to take part actively in road traffic and to operate machines may be impaired in isolated cases, this applies to a greater extent in combination with alcohol.
Ibuprofen Film-coated Tablets contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Ibuprofen Film-coated Tablets contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‚sodium-free‘.
3. how to take ibuprofen film-coated tablets
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Side effects may be minimised by using the lowest effective dose for the shortest possible duration necessary to control symptoms.
The lowest effective dose should be used for the shortest duration necessary to relieve symptoms. If you have an infection, consult a doctor without delay if symptoms (such as fever and pain) persist or worsen (see section 2).
| Body weight (Age) | Dose and how often to take |
| Adults, and adolescents = 40 kg (12 years old and above) | Take single dose (200 mg to 400 mg ibuprofen) with a glass of water, up to 3 times a day, as required. Do not take more often than every 6 hours. Do not take more than 1200 mg in any 24 hour period. |
| These tablets are intended for short-term use only. In adults : If this medicinal product is required for more than 3 days for fever or more than 4 days for pain, or if symptoms worsen a doctor should be consulted. In adolescents : If this medicinal product is required for more than 3 days, or if symptoms worsen a doctor should be consulted. | |
| Do not give to adolescents weighing under 40 kg or children under 12 years. | |
For oral use. It is recommended that patients with sensitive stomachs take Ibuprofen Film-coated Tablets with food.
Please speak to the doctor or pharmacist if you feel that the effect of this medicine is greater or less than you expected.
If you take more Ibuprofen Film-coated Tablets than you should:
Talk to a doctor straight away, or go to your nearest hospital casualty department. Take the carton and this leaflet with you. The following signs may occur: nausea, vomiting, stomach pain, diarrhoea, ringing in the ear, headache, gastrointestinal bleeding, dizziness, drowsiness, excitation, disorientation, coma, convulsions, prothrombin time/ INR prolonged, acute renal failure, liver damage, hypotension, respiratory depression, cyanosis, exacerbation of asthma in asthmatics.
If you forget to take Ibuprofen Film-coated Tablets
Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. possible side effects
Like all medicines, Ibuprofen Film-coated Tablets can cause side effects, although not everybody gets them
Side effects may be minimised by using the lowest effective dose for the shortest possible duration necessary to relieve the symptoms. You may suffer one of the known side effects of NSAIDs (see below). If you do, or if you have concerns, stop taking this medicine and talk to your doctor as soon as possible. Elderly people using this product are at increased risk of developing problems associated with side effects.
STOP TAKING this medicine and seek immediate medical help if you develop:
§ signs of intestinal bleeding such as: severe pain in the abdomen, black tarry stools, vomiting blood or dark particles that look like coffee grounds.
§ signs of very rare but serious allergic reaction such as swelling of the face, tongue or throat, difficulty breathing, racing heart, drop in blood pressure leading to shock. These can happen even on first use of this medicine.
§ severe skin reactions such as rashes covering the whole body, peeling, blistering or flaking skin.
Tell your doctor if you have any of the following side effects, they become worse or you notice any effects not listed.
Common (may affect up to 1 in 10 people)
§ gastrointestinal complaints, such as indigestion, heart burn, abdominal pain, feeling sick, vomiting, wind (flatulence), diarrhoea, constipation, and slight blood losses in stomach and/or bowel that may cause anaemia in exceptional cases.
§ rash
Uncommon (may affect up to 1 in 100 people)
§ rhinitis
§ allergic reactions with skin rash and itching, as well as asthma attacks (possibly with drop in blood pressure), worsening of asthma, difficulty in breathing (bronchospasm), shortness of breath (dyspnoe). If you have any of these symptoms you should stop taking this medicine and inform a doctor at once.
§ stomach or intestinal ulcers, sometimes with bleeding and perforation, inflammation of the lining of the mouth with ulceration (ulcerative stomatitis), inflammation of the stomach lining (gastritis), worsening of colitis and Crohn's disease
§ Central nervous disturbances such as headache, dizziness, sleeplessness, agitation, irritability or tiredness, pins and needles (paraesthesia).
§ visual disturbances
§ photosensitivity
§ hives, itching, purpura.
Rare (may affectup to 1 in 1,000people)
§ optic neuritis
§ toxic optic neuropathy
§ hearing imparied
§ tinnitus (ringing in the ears)
§ Vertigo
§ kidney tissue damage (papillary necrosis) and elevated uric acid concentrations in the blood
Very rare (may affect up to 1in 10,000 people)
§ inflammation of the oesophagus or pancreas, formation of membrane-like narrowing in the small and large intestines (intestinal, diaphragm-like strictures)
§ inflammation of blood vessels (vasculitis)
§ severe infections of the skin and soft-tissue complications have occurred during chicken pox (varicella) infection.
§ passing less urine than normal and swelling (especially in patients with high blood pressure or reduced kidney function).
§ cloudy urine (nephrotic syndrome), inflammatory kidney disease (interstitial nephritis) that may be accompanied by acute renal insufficiency.
§ psychotic reactions anxiety, confusional state and depression
§ exacerbation of infection-related inflammations (e.g. necrotising fasciitis) associated with use of certain painkillers (NSAIDs) has been described. If signs of an infection occur or get worse during use of Ibuprofen Tablets, you must go to a doctor without delay. It is to be investigated whether there is an indication for an anti-infective/antibiotic therapy.
§ high blood pressure, palpitations, heart failure, heart attack.
§ the symptoms of aseptic meningitis with neck stiffness, headache, feeling sick, being sick, fever or consciousness clouding have been observed when using ibuprofen. Patients with autoimmune disorders (SLE, mixed connective-tissue disease) may be more likely to be affected. Contact a doctor at once, if these occur.
§ severe forms of skin reactions such as skin rash with redness and blistering (e.g. Stevens-
§ Johnson syndrome, toxic epidermal necrolysis/Lyell's syndrome), hair loss (alopecia).
§ severe general hypersensitivity reactions.
§ problems in the blood cell production (leucopenia, thrombocytopenia, neutropenia, pancytopenia, agranulocytosis, anaemia including aplastic anaemia and haemolytic anaemia)- first signs are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe exhaustion, nose and skin bleeding. In these cases you must stop the therapy immediately and consult a doctor. Any self-treatment with pain killers or medicinal products that reduce fever (antipyretic medicinal products) mustn't be done.
§ Hepatic dysfunction, hepatic damage, particularly in long-term therapy, hepatic failure, acute hepatitis, jaundice (yellowing of the skin or the white of the eyes).
Not known
- A red, scaly widespread rash with bumps under the skin and blisters mainly localized on the skin folds, trunk, and upper extremities accompanied by fever at the initiation of treatment (acute generalised exanthematous pustulosis). Stop using Ibuprofen Tablets if you develop these symptoms and seek medical attention immediately. See also section 2.
5. how to store ibuprofen film-coated tablets
Keep this medicine out of the sight and reach of children.
Do not use the tablets after the expiry date which is stated on the carton and the blister, after EXP.
The expiry date refers to the last day of that month.
Keep the blisters in the outer carton in order to protect from light. This medicinal product does not require any special storage condition.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. contents of the pack and other information
What Ibuprofen film-coated tablets contains
§ The active substance is ibuprofen.
Each film-coated tablet contains 200 mg ibuprofen.
Each film-coated tablet contains 400 mg ibuprofen.
§ The other ingredients are:
Core : lactose monohydrate, maize starch, hypromellose, colloidal anhydrous silica, microcrystalline cellulose, croscarmellose sodium, magnesium stearate
Coating : hypromellose, titanium dioxide (E171), macrogol 6000, macrogol 400
What Ibuprofen 200 mg and 400 mg film-coated tablets look like and contents of the pack
Film-coated tablets
200 mg: White coloured, film coated pillow shaped tablets debossed with ‚235‘ on one side and plain on the other.
400 mg: White coloured, film coated pillow shaped tablets debossed with ‚236‘ on one side and plain on the other.
Pack sizes:
10, 12, 20, 24, 30, 48, 50, 60, 84, 100 tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Ascend Laboratories (UK) Ltd.
4th floor, Elsley Court 20–22
Great Titchfield Street
London, W1W 8BE
United Kingdom
Tel: 0800 047 0073
Manufacturer
Ascend Laboratories (UK) Ltd.
4th Floor, Cavendish House,
369 Burnt Oak Broadway
Edgware HA8 5AW
United Kingdom
and/or
Wave Pharma Limited
4th Floor, Cavendish House,
369 Burnt Oak Broadway
Edgware HA8 5AW
United Kingdom
Distributed by:
Ascend Laboratories (UK) Limited.
United Kingdom